1 What Amlodipine tablets are and what they are used for

Amlodipine belongs to a group of medicines called calcium antagonists. It is used to treat:

high blood pressure (hypertension).

angina pectoris (pain in the chest caused by blockages in the arteries leading to the heart) or chest pain classed as vasospastic angina pectoris (or Prinzmetal’s angina).

In patients with high blood pressure, your medicine works by relaxing blood vessels, so that blood passes through them more easily. In patients with angina, Amlodipine tablets works by improving blood supply to the heart muscle, which then receives more oxygen, and as a result chest pain is prevented.

Your medicine does not provide immediate relief of chest pain from angina.

2 Before you take

Do not take Amlodipine tablets and tell your doctor if you:

are allergic (hypersensitive) to Amlodipine tablets, dihydropyridine derivatives, amlodipine or any of the other ingredients (see section 6) or to any other calcium antagonists. This may itching, reddening of the skin or difficulty in breathing

are in shock including shock caused by heart problems (a condition where your heart is unable to supply enough blood to the body)

suffer from an obstruction in the heart caused by an extreme narrowing of the heart valves (aortic stenosis)

suffer from heart failure after a heart attack

have severe low blood pressure (hypotension)

Use in children and adolescents

Safety and effectiveness have been studied in 6-17 year old boys and in girls. Amlodipine should only used for hypertension in children and adolescents from 6 years to 17 years of age. Amlodipine has not been studied in children under the age of 6 years. For more information, talk to your doctor.

Take special care with Amlodipine tablets and tell your doctor if you:

have liver problems

have recent heart attack

have heart failure

are elderly, your doctor may monitor you closely

severe increase in blood pressure (Hypertensive crisis)

Taking other medicines

Before taking Amlodipine tablets, tell your doctor if you are taking or have taken recently any of the following medicines or are taking any non-prescribed medicines:

Amlodipine tablets may lower your blood pressure even more if you are already taking other medicines to treat your high blood pressure.

Taking Amlodipine tablets with food and drink

Grapefruit juice and grapefruit should not be consumed by people who are taking Amlodipine tablets. This is because grapefruit and grapefruit juice can lead to an increase in the blood levels of the active ingredient amlodipine, which can cause an unpredictable increase in the blood pressure lowering effect of Amlodipine tablets.

Pregnancy

The safety of Amlodipine in human pregnancy has not been established. If you think you might be pregnant, or are planning to get pregnant, you must tell your doctor before you take Amlodipine tablets.

Breast-feeding

It is not known whether amlodipine is passed in to breast milk. If you are breast-feeding or about to start breast-feeding you must tell your doctor before taking Amlodipine tablets.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Amlodipine tablets may cause dizziness, headaches, tiredness or feeling sick. Any of these side effects would reduce your ability to react, do not drive or use machinery if you are affected.

3 How to take

Always take Amlodipine tablets exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

Your medicine can be used before or after food and drinks. You should take your medicine at the same time each day with a glass of water. Do not take Amlodipine tablets with grapefruit juice.

Usual doses:

Adults (including the elderly and children 18 years or over):
5mg once a day, up to a maximum of 10mg a day as a single dose depending on your response. If you are elderly, your doctor will closely monitor your response to any dose increase.

Use in Children and adolescents (6 -17 years old): the recommended usual starting dose is 2.5mg a day. The maximum recommended dose is 5mg a day. Amlodipine 2.5mg is not currently available and the 2.5mg dose cannot be obtained with Amlodipine tablets 5mg as these tablets are not manufactured to break into two equal halves.

Patients with impaired liver function: your doctor may prescribe you a different dose.

It is important to keep taking the tablets. Do not wait until your tablets are finished before seeing your doctor.

If you take more Amlodipine tablets than you should

Taking too many tablets may cause your blood pressure to become low or even dangerously low. You may feel dizzy, lightheaded, faint or weak. If blood pressure drop is severe enough shock can occur. Your skin could feel cool and clammy and you could lose consciousness. Seek immediate medical attention if you take too many Amlodipine tablets.

If you forget to take the Amlodipine tablets

Do not worry. If you forget to take a tablet, leave out that dose completely. Take your next dose at the right time. Then go on as before. Never double up on the next dose to make up for the one missed.

If you stop taking Amlodipine tablets

Do not interrupt or stop treatment with Amlodipine tablets without consulting your doctor, as your symptoms could return or ‘flare-up’.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

A disorder of the nerves which can cause weakness, tingling or numbness (peripheral neuropathy)

Cough, swelling of the gums

Abdominal bloating (gastritis)

Abnormal liver function, inflammation of the liver (hepatitis causing tiredness, pain in abdomen, joints or muscles), yellowing of the skin or whites of the eyes (jaundice), liver enzyme increase (detected in blood test) which may have an effect on some medical tests

Increased muscle tension

Inflammation of blood vessels (vasculitis), often with skin rash

Sensitivity to light

Disorders combining rigidity, tremor, and/or movement disorders

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.